Rev 140109

D.750.09/PP/001C v1

Purified Human Fibrinogen
Fibrinogne humain purifi
Vial of 1 g/flacon de 1 g

Ref. APP001C


STORE AT
2-8C
For research use only

BioHazard
Uniquement usage de recherche
CONSERVER A
2-8C



Origin:
Highly purified from citrated human plasma
Presentation:
Vial containing approximately 1 g of highly purified human fibrinogen.
Reconstitution:
Each vial must be restored with 50 ml distilled water in order to obtain a
20 mg/ml fibrinogen solution. Incubate preferentially at 37C, until complete
dissolution. Shake gently, avoiding formation of foam. Total dissolution of
fibrinogen content may require 1 hour or more. This solution can be diluted to
the desired concentration when required.
Excipients:
Glycine, trisodium citrate and sodium veronal buffer
270 mg sodium chloride/vial
Purity:
One major band of 340,000 daltons on SDS-PAGE. This fibrinogen has a
clottability 98%.
Activity:
Tested for the clotting activity induced by thrombin. When the fibrinogen, at 5
mg/ml (100 l), is clotted by thrombin, at 5 NIH/ml (100 l), the clotting time
must be below 15 sec.
Viral safety:
The plasma used for fibrinogen purification was tested with registered
methods and found negative for HIV antibodies, HBs Ag and HVC antibodies.
However, no assay may warrant the total absence of infectious agents. Any
product of human origin must then be handled with all the required cautions,
as being potentially infectious.
Use:
For in vitro use only.
All research studies and protocols where a source of highly purified fibrinogen
is necessary.
Stability:
Restored : - 48 hours at room temperature
- 96 hours at 2-8 C
Lyophilized : Until the expiration date printed on the vial.


Origine :
Protine hautement purifie extraite de plasma humain citrat.
Prsentation :
Flacon contenant environ 1 g de fibrinogne humain.
Reconstitution:
Chaque flacon doit tre reconstitu par 50 ml d'eau distille afin d'obtenir
une solution 20 mg/ml de fibrinogne. Incuber de prfrence 37C,
jusqu' dissolution complte. Agiter dlicatement en vitant la formation de
mousse. La dissolution totale du fibrinogne peut ncessiter 1 heure ou
davantage. Ce fibrinogne peut tre dilu la concentration requise, si
ncessaire.
Excipients :
Glycine, trisodium citrate et vronal sodique.
270 mg de chlorure de sodium/flacon
Puret :
Bande principale de 340 000 daltons sur SDS-PAGE. Ce fibrinogne a une
coagulabilit 98%.
Activit :
Test pour l'activit coagulante induite par la thrombine. Lorsque le
fibrinogne, 5 mg/ml (100 l), est coagul par la thrombine 5 NIH/ml
(100 l) le temps de coagulation doit tre infrieur 15 sec.
Scurit virale :
Le plasma utilis pour la purification du fibrinogne a t test par des
mthodes enregistres et est certifi exempt d'anticorps VIH, de Hbs Ag et
d'anticorps VCH. Toutefois, aucune mthode ne permettant d'exclure
totalement le risque d'agent pathogne, ces produits doivent tre manipuls
avec toutes les prcautions requises pour l'utilisation de produits
potentiellement infects.
Utilisation :
Utilisation in vitro exclusivement.
Toutes les tudes ou protocoles dans lesquels l'utilisation d'une source de
fibrinogne hautement purifi est ncessaire.
Stabilit du flacon:
Reconstitu : - 48 heures temprature ambiante
- 96 heures 2-8 C
Lyophilis : Jusqu' la date de premption indique sur le flacon.

Rev 140109
D.750.09/PP/001C v1
DATE : CONCLUSIONS : Passed/Conforme Refused/Non-conforme Quality Control Manager
Responsable contrle qualit

Purified Human Fibrinogen
Fibrinogne humain purifi
Vial of 1 g/flacon de 1 g

Ref. APP001C

STORE AT
2-8C
Lot:

BioHazard
Expiration:
CONSERVER A
2-8C

ANALYSIS CERTIFICATE
ANALYTICAL DATA SPECIFICATIONS
1. Protein Content (Lowry method )
.. mg/vial > 900 mg/vial
2. SDS-PAGE (5 % acrylamide)
1 single band of about .. daltons 1 major band of about
340,000 daltons
3. Clotting time (5 NIH/ml Thrombin)
.. sec < 15 sec
4. Coagulability
.. % 98%

CERTIFICAT D'ANALYSE
RESULTATS D'ANALYSE SPECIFICATIONS
1. Teneur protique (Mthode Lowry )
.. mg/flacon > 900 mg/flacon
2. SDS-PAGE (5 % acrylamide)
1 bande d'environ .. daltons 1 bande principale
340 000 daltons
3. Temps de coagulation (Thrombine 5 NIH/ml)
.. sec < 15 sec
4. Coagulabilit
.. % 98%